HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM— 510(k) K863783

Substantially Equivalent

Hzi Research Center

FDA 510(k) clearance K863783 for HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM, Substantially Equivalent on 1987-03-03. Applicant: Hzi Research Center.

Clearance details

Applicant: Hzi Research Center
Product code: Code OLT
Advisory panel: Neurology
Date received: 1986-09-26
Decision date: 1987-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.